Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Heinz Italia SpA
- Enrollment
- 148
- Locations
- 2
- Primary Endpoint
- The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms
Study Overview
Brief Summary
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants.
Detailed Description
Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable.
New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.
The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation.
The aim of this study is to verify the safety of the study formula in healthy term infants and to deepen the efficacy of the functional ingredient blend in term of prebiotic effect, gastrointestinal tolerance and immune response improvement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 21 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants of both sexes born to natural or cesarean delivery
- •Gestational age between 37 and 42 completed weeks
- •Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
- •Single birth
- •Caucasian parents
- •Infants being exclusively formula-fed by the 21st day of life
Exclusion Criteria
- •Infants with genetic and/or congenital diseases
- •Infants receiving antibiotic therapy
- •Infants with neonatal diseases requiring hospitalisation for longer than 7 days
- •Infants at risk for atopy and/or having familial history for atopy
- •Mothers with metabolic or chronic diseases
- •Infant selected for another clinical study
- •Parents refusing to sign a written informed consent
Outcomes
Primary Outcomes
The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms
Time Frame: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.
Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.
Secondary Outcomes
- Immune-modulatory activity(At enrolment, after 60 and 135 days of life)
- Prebiotic effect(At enrolment and after 135 days of life)